21 C.F.R. § 862.2560

Current through September 30, 2024
Section 862.2560 - Fluorometer for clinical use
(a)Identification. A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9 .

21 C.F.R. §862.2560

52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000